COVID-19 Clinical Trial
Official title:
Reducing Hospital Admission of Elderly in SARS-CoV-2 Pandemic Via the Induction of Trained Immunity by Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial
Bacillus Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has also
been shown to induce protection against various infections with a viral aetiology, leading to
significant reductions in morbidity and mortality. We hypothesize that BCG vaccination might
be a potent preventive measure against SARS-CoV-2 infection and/or may reduce disease
severity in elderly people, who are known to be at increased risk of illness and death from
SARS-CoV-2 infection.
Therefore, we will in this placebo-controlled adaptive multi-centre randomized controlled
trial evaluate the ability of BCG to reduce hospital admission and its efficacy to improve
the clinical course of SARS-CoV-2 infection in elderly people((≥ 60 years of age).
On March 11 2020 the World Health Organization (WHO) declared the coronavirus (SARS-CoV-2)
outbreak a pandemic. The number of confirmed cases continues to rise, leading to significant
morbidity and mortality worldwide. Although individuals of any age can acquire SARS-CoV-2,
adults of middle age and older are most commonly affected. Moreover, recent reports
demonstrate that mortality rates rise significantly among patients 60 years and older.
Therefore, strategies to prevent SARS-CoV-2 infection or to reduce its clinical consequences
in elderly are desperately needed. Bacillus Calmette-Guérin (BCG) vaccine not only protects
against tuberculosis, but has also been shown to induce protection against various infections
with a viral aetiology, leading to significant reductions in morbidity and mortality. We
hypothesize that BCG vaccination may reduce hospital admission and improve the clinical
course of symptoms of elderly people during the SARS-CoV-2 outbreak. Primary objective: To
reduce hospital admission of community dwelling older persons during the pandemic of
SARS-CoV-2. Secondary objective: To reduce disease severity, the duration of hospital
admission, ICU admission, or death in elderly during the pandemic of SARS-CoV-2.
Study design: A placebo-controlled adaptive multi-centre randomized controlled trial.
Study population: Elderly people (≥ 60 years of age). Intervention: Participants will be
randomized between intracutaneous administration of BCG vaccine or placebo in a 1:1 ratio.
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